Pharmaceutical, chemical, biological, biochemical or biotech processes are performed in increasing measure in single-use containers (also referred to as disposables, or disposable bioreactors). Such single-use containers can be, for example, flexible containers, e.g. bags, hoses or fermenters, respectively bioreactors. Bioreactors or fermenters possess, frequently, supply and drain lines, which can be embodied, for example, as hoses or flexible tubing. Applied in the supply and drain lines can also be rigid tubular pieces. After terminating a process, the single-use container can be disposed of. In this way, complex cleaning- and sterilization methods are avoided. Especially, through the use of single use containers, the risk of cross contaminations is avoided and therewith, bio- and process safety is increased. The single-use containers are, as a rule, produced from synthetic material, e.g. plastic.
The processes running in single-use containers are closed off from the environment. Since, frequently, sterile conditions are required, the single-use containers must be sterilized before introducing the process media. To this end, frequently, gamma radiation is used in biochemical, biological, biotechnological and pharmaceutical applications. Also, while the processes are running in a single-use fermenter or non-returnable reactor, the penetration of germs from the environment into the interior of the container must be prevented, in order not to degrade or corrupt the process.
In order to monitor or control the processes, it can be necessary to measure physical or chemical, measured variables of the media in the container. Monitored measured variables can include, for example, temperature, pH-value, cell density, optical transmission or concentration of a chemical substance, for example, a certain kind of ion or a certain element or a certain compound.
An opportunity for measuring at least some of these measured variables lies in the application of optical sensors. For example, there can be arranged in the flexible container active surfaces capable of being read out optically by sensor. These surfaces, which are referred to as ‘optical sensor spots’, can be scanned contactlessly from the outside through a window. The fluorescent dyes used for the sensor spots can, however, be sensitive to the gamma radiation frequently used in biotechnological and pharmaceutical applications for sterilization as well as also being sensitive to aggressive chemical conditions, such as can occur especially in the case of the purification of biotechnologically manufactured products.
European patent application EP 2 065 701 A2 describes probes, which can be arranged in a flexible, single-use container, and which can, via an inductive interface, exchange data with a measurement transmitter arranged outside of the container.
The measurement transmitter can also supply the probes with energy via the inductive interface. Data and energy can, in this way, be transmitted inductively through the container wall without requiring an opening for the probe or at least supply lines to the probe. In order to implement inductive transmission of data and energy between the probe and the measurement transmitter, electronic circuits are required, both on a primary side as well as also on a secondary side of the inductive interface. These circuits cannot withstand the gamma radiation used for sterilizing the flexible container and the probe.
International patent application WO 2009/071829 A2 and German Offenlegungsschrift DE 10 2006 005 533 A1 describe complex mechanical coupling systems, which enable sterile introduction of an externally sterilized probe into a single-use container.
Known from German Gebrauchsmuster DE 20 2007 000 152 U1 is an apparatus for securement of an optical probe to a container with flexible wall, in the case of which the probe lies with a rear surface portion on an inner side of the container wall and is led with a central piece through an opening of the container wall, wherein the central piece is affixed to the container wall by clamping.